W4TR06 Solara Quad CRTP MRI SureScan
Cardiac Resynchronization Therapy - Pacing (CRT-Pacing)
W4TR06 Solara Quad CRTP MRI SureScan
Information

Device Survival Probability

W4TRXX_SURV
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    at 10.0 mo                  
% Excluding Normal Battery Depletion 100.0                  
% Including Normal Battery Depletion 100.0                  
#   172                  
  • Including Normal Battery Depletion – This curve includes devices that have reached at least 80% of expected longevity. This curve is most representative of clinical performance and how long the device will last.
  • Excluding Normal Battery Depletion – This is the malfunction free survival curve.
Information

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

    • There are no performance notes for this model.
Information

Product Characteristics

Generator Type CRT-Pacing
NBD Code OAE-DDDR
Max. Delivered Energy N/A
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Serial Number Prefix RNZ
Mass 30 g
Volume 20.5 cc
Waveform N/A
X-Ray ID RNP
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Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 8.7 10.9
Nominal 3.5 V (A, RV) 6.9 8.5
High 5.0 V (A, RV) 3.9 6.0
Footnote

Longevity estimates based on the following device usage.   Pace/Sense Mode DDD ; Atrial Pulse Width 0.4 ms; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; Left Ventricle Pulse Width 0.4 ms; Left Ventricle Pulse Amplitude same as A, RV; Left Ventricle Percent Paced 100 %; Left Ventricle Lead Impedance same as A, RV; EGM Prestorage ON ; EGM Prestorage ON Time 1 ; Atrial Fib Percent of Time 0 % Hide this content

Information

Distribution Data

US Market Release
CE Approval Date2017-02-10
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release
CE Approval Date2017-02-10
Estimated WW Distribution915
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
Information

EOS Indication

6 months after RRT

Information

Recommended Replacement (RRT)

180 days after 3 consecutive daily automatic measurements of ≤ 2.63 V or immediately after 3 consecutive daily automatic measurements of ≤ 2.60 V, whichever comes first

Data as of January 31, 2018

www.medtronic.com/productperformance 601051